Favorable Safety Profile Seen With Sabizabulin in mCRPC

Mark Markowski, MD, PhD, assistant professor of oncology, at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medical Oncology, discusses the results of a phase 1b/2 study (NCT03752099) examining treatment with sabizabulin (VERU-111) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Markowski noted that overall, sabizabulin was found to be safe and only mild toxicities were reported in phase 1 of the trial. Patients primarily had grade 1 or 2 adverse events, including fatigue and GI toxicities.

In the phase 2 portion of the study, some tumor reduction was seen, the overall response rate was in the 20% to 30% range, and the median progression-free survival was between 9-12 months.

Transcription:

0:08 | For the phase 1, dose finding study looking at safety, we did find that sabizabulin was pretty safe. It had mild toxicity, grade 1 or 2 primarily, and mostly fatigue and GI toxicities were diarrhea, nausea, and most patients did very well. We had a few grade 3 toxicities in the GI tract. Those were managed well with dose interruption or dose reduction. Again, from the safety perspective, patients did quite well in phase 1.

0:40 | Then we did see preliminary activity in phase 2. We saw some tumor reduction; we had an objective response rate in the 20% to 30% range. What we found is that patients were on the study for a long time. Progression-free survival was in the range of 9 to 12 months, but we had patients on study for 3 years and they continue on the study. There was some good disease control and in addition to some of the responses in terms of tumor reduction, we saw a lot of disease stability that was durable, so we were happy with it.